Duns Number:529309049
Device Description: 6.5oz clear beaker + 2 x 30ML Siamese tubes + biobags with absorbent cotton
Catalog Number
-
Brand Name
Gongdong
Version/Model Number
Q127
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNI
Product Code Name
Container, Specimen, Non-Sterile
Public Device Record Key
2ae0ea10-1901-4f62-a997-100687065eff
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
Package DI Number
06947462401607
Quantity per Package
25
Contains DI Package
86947462401603
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |